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Glenmark Receives USFDA ANDA Approval for Abiraterone Acetate Tablets USP, 250 mg


Glenmark Receives USFDA ANDA Approval for Abiraterone Acetate Tablets USP, 250 mg

MUMBAI — Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Abiraterone Acetate Tablets USP, 250 mg, a generic version of Zytiga®1 Tablets, 250 mg, of Janssen Biotech, Inc.

According to IQVIA™ sales data for the 12 month period ending August 2019, the Zytiga® Tablets, 250 mg market2 achieved annual sales of approximately $794.1 million*.

Glenmark’s current portfolio consists of 162 products authorized for distribution in the U.S. marketplace and 46 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

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The company has a significant presence in the branded generics markets across emerging economies including India. Glenmark has 16 manufacturing facilities across five countries and has six R&D centers. The Generics business of Glenmark services the requirements of the US and Western European markets. The API business sells its products in over 80 countries, including the US, various countries in the EU, South America and India.

Read Also: Glenmark gets tentative USFDA nod for generic version of Tecfidera Capsules


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